StrataMGT for the Treatment of Vulvar Lichen Sclerosus

NCT06360705 | Completed FDA Device

• 1 other identifier: CVVD003
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to evaluate the efficacy and safety of StrataMGT for the treatment of vulvar lichen sclerosus.

Conditions

Vulvar Lichen Sclerosus

Outcome Measures

Primary Outcomes (1)

• Histopathologic Inflammation

  Histopathologic inflammation that occurs with lichen sclerosus will be assessed by a dermatopathologist on 4mm punch biopsies performed during the screening visit (Week 0) and at the Week 10 visit using the following clinical scoring scale. The scale is from 0-3, 0 being no disease of inflammation and 3 being severe disease or inflammation.

  10 weeks

Study Arms (1)

Exploratory Open Label

EXPERIMENTAL

Experimental: StrataMGT

Device: StrataMGT

Interventions

StrataMGT DEVICE

StrataMGT® is a semi-permeable, non-resorbable and self-drying gel. StrataMGT® contains no steroids, hormones, alcohol, parabens or fragrances. StrataMGT® gel is bacteriostatic, inert, and is manufactured in compliance with good manufacturing practices (GMPs), 21CFR210 and 211.

Exploratory Open Label

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: cis-gendered female patients
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects to be included are those:
• Female, 18 years or older.
• With a diagnosis of biopsy proven vulvar lichen sclerosus.
• Signed written informed consent.
• Willingness and ability to comply with the study requirements.
• Subject must have a score of 16 or greater in the VQLI at screening.
• Women must have a culture negative for candidiasis or bacterial vaginosis at screening. Subjects who screen positive for either candidiasis or bacterial vaginosis at the screening visit may be treated and retested and may participate if the confirmatory test after treatment is negative. Any vulvovaginal infections during participation in the study will be considered an adverse event. The subject will then stop the study IP and will be treated for the infection and may resume use of the IP 3 days after the last dose of medication for the infection. Participants will be discontinued from the study if participants have two infections during the study.

You may not qualify if:

• Subjects to be excluded are those:
• Who have received systemic immunosuppressants (e.g. corticosteroids) within 12 weeks prior to participation in the study.
• Who have been treated with topical therapy (e.g., topical corticosteroids, topical calcineurin inhibitors, topical estrogen, topical testosterone) at the affected area within 12 weeks prior to participation in the study.
• Who use topical emollients, lubricants (other than for penetrative intercourse),or any other topical products for symptom control at the affected area within 4 weeks prior to participation in the study.
• Prior history of, or active Vulvar Intraepithelial Neoplasia (VIN) or vulvar carcinoma.
• Who are immunocompromised (e.g., lymphoma, AIDS, Wiskott-Aldrich Syndrome) or have an uncontrolled malignant disease.
• Who suffer from systemic or generalized infections (bacterial, viral or fungal).
• Who have been diagnosed with lichen planus, psoriasis, candidiasis, intraepithelial neoplasia, or carcinoma of the vulva.
• Who had received an investigational drug within four weeks prior to the study or who intend to use other investigational drugs during the course of this study.
• Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study.
• Who have a history of substance abuse or any factor, which limits the subject's ability to cooperate with the study procedures.
• Who are uncooperative, known to miss appointments (according to subjects' records) and are unlikely to follow medical instructions or are not willing to attend regularly scheduled visits.

Sponsors & Collaborators

• Center for Vulvovaginal Disorders: lead
• Stratpharma AG: collaborator

Study Sites (1)

Centers for Vulvovaginal Disorders

New York, New York, 10036, United States

Location

MeSH Terms

Conditions

Vulvar Lichen Sclerosus

Condition Hierarchy (Ancestors)

Vulvar Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2024
• First Posted: April 11, 2024
• Study Start: April 16, 2024
• Primary Completion: October 30, 2024
• Study Completion: November 30, 2024
• Last Updated: February 7, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)